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Asynchrony in Operated Tetralogy of Fallot

Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05485545
Acronym
FALLOT-XI
Enrollment
0
Registered
2022-08-03
Start date
2022-09-01
Completion date
2024-09-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot

Keywords

FALLOT disease, CARTO, 3Dimension Echocardiography, mecanichal and electrical activation

Brief summary

The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.

Detailed description

Fallot tetralogy is the most common cyanogenic congenital heart disease. Thanks to advances in surgery, most patients survive to adulthood but develop a failure of the function of the right ventricle and then of the left ventricle resulting in progressive heart failure and death of patients. Despite corrective surgeries in adulthood, including pulmonary valve surgery, heart failure remains a major problem. One of the mechanisms of this heart failure is the right intraventtricular asynchronism associated with the postoperative right branch block, which will secondaryly become complicated from an interventricular asynchronism for left intraventtricular, partly explaining the overall progressive failure of cardiac function. To date, there is no model for combining a combined analysis of electrical and mechanical activation in the same patients. Understanding these mechanisms would allow us to better understand the pathophysiology of heart failure in this population and to propose targeted therapies to prevent this asynchronism by adapting surgical techniques, or treating this asynchronism with electrical therapy such as bivascular resynchronization. Each patient in each group will perform, according to standard practice, an electrophysiological exploration with mapping of the heart using the CARTO system, a cardiac MRI and a 3-dimensional transthoracic echocardiography. The follow-up of each patient takes place during a scheduled hospitalization as part of the care. Their participation in the study only lasts for the duration of the hospitalization.

Interventions

OTHERElectrophysiological exploration of the right ventricle

* CARTO electrophysiological mapping system * 3D echocardiography * High Resolution MRI

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER
Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria in the Fallot group * Male or female patient aged 18, * Patient with Fallot Tetralogy operated. nclusion Criteria in the Control group * Male or female patient aged 18, * Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia, * Patient with a significant lack of heart disease.

Design outcomes

Primary

MeasureTime frame
Comparison of electrical and mechanical activation by computational morphometry with temporal recalling to define electromechanical activation maps in healthy subjects and patients with Fallot tetralogy operated.Day 0

Secondary

MeasureTime frameDescription
Area strain VD 3D global in %Day 0Global 3D VD longitudinal strain in %, Global 3D VD circumferential strain in %, Mean deformation pattern, Mean RV right ventricle shape, RV Average Curvature Index.
Strain longitudinal VD 3D at the 8 segments in %Day 0
Strain circumferential VD 3D at the 8 segments in %Day 0
Comparison of 3D VD volume data between different populationsDay 03D VD Ejection Fraction and End-Diastolic and End-Systolic Volume 3D VD; 3D right ventricle volume data processed by Tomtec 4D RV Function 2.0.
Inter-evaluator variability of 3D deformation parametersDay 0Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.
Intra-evaluator variability of 3D deformation parametersDay 0Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.
MR AnalysisDay 0* Right and Left Ventricular MRI Volumetry; * Pulmonary flow by MRI. * T1 spontaneous (ms) and extracellular volume fraction (%) by MRI * MRI scar area
Comparison of electrical activation maps based on anatomical dataDay 0Comparison of electrical activation maps based on anatomical data, including diffuse fibrosis and scars in Fallot subjects

Countries

France

Contacts

STUDY_DIRECTORXavier IRART, MD

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026